FDA to regulate genetic diagnostic tests, will affect cancer testing

The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye.

More than 11,000 of these tests, known as laboratory-developed tests, created by 2,000 different laboratories, could be included in the new regulatory framework, according to the FDA. The agency made its plans public in a guidance document that was sent to Congress, as part of legal direction by legislators.

The FDA’s plan is to enforce regulations based on the amount of risk that a test poses to a patient. Tests that are used to diagnose a disease or to decide on a course of treatment will need to be cleared by the FDA before they can be marketed.

Some tests will be excluded from the new requirements: those used in the treatment of very rare diseases where there is no other test; those that resemble the low-tech tests that FDA originally planned not to regulate; and some tests involved in organ transplants.

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But the new policy is likely to have a big impact on the increasingly common practice of using genetics to decide how to treat cancer patients.

Read the full, original story: FDA to regulate thousands of cancer, genetic, and other diagnostics